Journal of orthopaedic trauma · 2020
Taylor Spatial Frame or Reamed Intramedullary Nailing for Closed Fractures of the Tibial Shaft: A Randomized Controlled Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Frihagen Frede, Madsen Jan E, Sundfeldt Mikael, Flugsrud Gunnar B, Andreassen Joakim S, Andersen Mette R, Andreassen Geir S
Аннотация
OBJECTIVES: To compare a modern ring fixator [Taylor Spatial Frame (TSF)] and reamed intramedullary nailing (IMN) for the treatment of closed tibial shaft fractures.
DESIGN: Randomized controlled trial.
SETTING: Two university hospitals.
PATIENTS: Patients between 18 and 70 years of age surgically treated for an acute tibial shaft fracture.
INTERVENTION: TSF (n = 31) versus a reamed intramedullary nail (n = 32). The patients were followed up for 2 years.
MAIN OUTCOME MEASUREMENTS: The physical component summary of Short Form 36 (SF-36) at 2 years was the primary outcome measure. Secondary outcomes included the other components of the SF-36, pain assessed by a visual analogue scale (VAS), complications, and resource consumption.
RESULTS: The mean age was 43 years (SD 14.0), and 42 (67%) were men. The physical component summary at 2 years was 52.4 (SD 6.3) in the TSF group and 53.3 (SD 8.0) in the IMN group (P = 0.35). There were modest differences in the other SF-36 scores during the follow-up period. Up to and including 12 months, the TSF group had less knee pain [at 12 months: VAS 0.5 (SD 1.2) vs. VAS 2.4 (SD 2.2; P < 0.001)], but this was not statistically significant at 24 months [VAS 0.7 (SD 1.4) vs. VAS 1.5 (SD 2.0; P = 0.11)]. Superficial skin infections were more frequent in the TSF group [22 (71%) vs. 4 (13%); P < 0.001]. The number of other complications was similar between the groups.
CONCLUSIONS: Both TSF and IMN provided good clinical results. TSF had more pin-track infections but less knee pain the first year.
LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
DESIGN: Randomized controlled trial.
SETTING: Two university hospitals.
PATIENTS: Patients between 18 and 70 years of age surgically treated for an acute tibial shaft fracture.
INTERVENTION: TSF (n = 31) versus a reamed intramedullary nail (n = 32). The patients were followed up for 2 years.
MAIN OUTCOME MEASUREMENTS: The physical component summary of Short Form 36 (SF-36) at 2 years was the primary outcome measure. Secondary outcomes included the other components of the SF-36, pain assessed by a visual analogue scale (VAS), complications, and resource consumption.
RESULTS: The mean age was 43 years (SD 14.0), and 42 (67%) were men. The physical component summary at 2 years was 52.4 (SD 6.3) in the TSF group and 53.3 (SD 8.0) in the IMN group (P = 0.35). There were modest differences in the other SF-36 scores during the follow-up period. Up to and including 12 months, the TSF group had less knee pain [at 12 months: VAS 0.5 (SD 1.2) vs. VAS 2.4 (SD 2.2; P < 0.001)], but this was not statistically significant at 24 months [VAS 0.7 (SD 1.4) vs. VAS 1.5 (SD 2.0; P = 0.11)]. Superficial skin infections were more frequent in the TSF group [22 (71%) vs. 4 (13%); P < 0.001]. The number of other complications was similar between the groups.
CONCLUSIONS: Both TSF and IMN provided good clinical results. TSF had more pin-track infections but less knee pain the first year.
LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.